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Roxatidine acetate hydrochloride slow-release capsules and preparation method thereof

A technology of roxatidine hydrochloride acetate and sustained-release capsules is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, and can solve problems such as no domestic and foreign literature reports, etc., Achieve the effect of improving medication compliance, less coating loss, and reducing the number of doses

Pending Publication Date: 2019-11-05
FUZHOU MINHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to technical barriers, Roxatidine Hydrochloride Acetate Sustained Release Capsules has not yet been listed in the domestic market, and there are no domestic and foreign literature reports on the preparation method of Roxatidine Hydrochloride Acetate Sustained Release Capsules

Method used

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  • Roxatidine acetate hydrochloride slow-release capsules and preparation method thereof
  • Roxatidine acetate hydrochloride slow-release capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] 1), Preparation of drug-loaded pellets:

[0040] (1) Weigh 600.0 g of purified water and add it to the liquid mixing tank, start stirring, add 750.0 g of roxatidine hydrochloride acetate, and stir to dissolve.

[0041] (2), take 675.0g of sucrose ball core, place in the bottom spray fluidized bed, set material temperature 50 ℃ to carry out drug-containing layer pellet coating, coating time 2 hours;

[0042] (3), after coating, dry to moisture<0.5%;

[0043] (4), sieving the dried ball core to obtain drug-loaded pellets;

[0044] 2), preparation of sustained-release pellets:

[0045] (1) Weigh 750.0g of ethanol and 300.0g of purified water, add them to the liquid mixing tank, start stirring, add 75.0g of ethyl cellulose, stir until dissolved, then add 7.5g of triethyl citrate and colloidal Silicon dioxide 7.5g, stir well;

[0046] (2) Place the drug-loaded pellets in the bottom spray fluidized bed, set the temperature of the material at 30°C to coat the pellets with ...

Embodiment 2

[0052] 1), Preparation of drug-loaded pellets:

[0053] (1) Weigh 750.0 g of purified water and add it to the liquid mixing tank, start stirring, add 750.0 g of roxatidine hydrochloride acetate, and stir to dissolve;

[0054] (2), take 712.5g of sucrose ball core, place in the bottom spray fluidized bed, set material temperature 55 ℃ to carry out drug-containing layer pellet coating, coating time 3 hours;

[0055] (3), after coating, dry to moisture<0.5%;

[0056] (4), sieving the dried ball core to obtain drug-loaded pellets;

[0057] 2), preparation of sustained-release pellets:

[0058] (1) Weigh 1125.0g of ethanol and 450.0g of purified water, add them to the liquid mixing tank, start stirring, add 112.5g of ethyl cellulose, stir until dissolved, then add 11.2g of triethyl citrate and colloidal Silicon dioxide 11.2g, stir well;

[0059] (2) Place the drug-loaded pellets in the bottom spray fluidized bed, set the temperature of the material at 35°C to coat the pellets w...

Embodiment 3

[0065] 1), Preparation of drug-loaded pellets:

[0066] (1) Weigh 900.0 g of purified water and add it to the liquid mixing tank, start stirring, add 750.0 g of roxatidine hydrochloride acetate, and stir to dissolve;

[0067] (2), take 750.0g of sucrose ball core, place in the bottom spray fluidized bed, set material temperature 60 ℃ to carry out drug-containing layer pellet coating, coating time 4 hours;

[0068] (3), after coating, dry to moisture<0.5%;

[0069] (4), sieving the dried ball core to obtain drug-loaded pellets;

[0070] 2), preparation of sustained-release pellets:

[0071] (1) Weigh 1500.0g of ethanol and 600.0g of purified water, add them to the liquid mixing tank, start stirring, add 150.0g of ethyl cellulose, stir until dissolved, then add 15.0g of triethyl citrate and colloidal Silicon dioxide 15.0g, stir well;

[0072] (2) Place the drug-loaded pellets in the bottom spray fluidized bed, set the material temperature to 40°C to coat the sustained-release ...

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Abstract

The invention discloses roxatidine acetate hydrochloride slow-release capsules and a preparation method thereof. A main medicine is roxatidine acetate hydrochloride, auxiliary materials consist of blank pill cores, slow release materials, a plastifier and a pore-forming agent, wherein the weight ratio of the roxatidine acetate hydrochloride to the blank pill cores to the slow release materials tothe plastifier to the pore-forming agent is 1.00 to (0.90-1.00) to (0.10-0.20) to (0.01-0.02) to (0.01-0.02). A preparation method of the roxatidine acetate hydrochloride slow-release capsules disclosed by the invention is simple and convenient to operate, good in inter-batch repeatability and easy in amplified production. The coating effects are good, during coating, good film forming characteristics of a coating solution are maintained, the coating uniformity is good, and the loss of the coating solution can be reduced. The dissolving-out behaviors of the roxatidine acetate hydrochloride slow-release capsules in four kinds of dissolving-out mediums of water, a dissolving-out medium of which the pH is 1.2, a dissolving-out medium of which the pH is 4.0 and a dissolving-out medium of whichthe pH is 6.8 are consistent in those of an original developing agent.

Description

technical field [0001] The invention relates to a sustained-release capsule of roxatidine hydrochloride acetate and a preparation method thereof. Background technique [0002] Roxatidine acetate hydrochloride is the fourth generation of histamine H 2 Receptor blocker, developed by Nippon Tsang Pharmaceutical Co., Ltd., was first approved by the Ministry of Health and Welfare of Japan in 1986. In vivo, this product is rapidly converted to the active metabolite roxatidine after deacetylation by hydrolysis, which can selectively block the histamine H 2 Receptor, can inhibit the gastric acid secretion caused by histamine, pentagastrin, M cholinergic receptor agonist in animals and humans, the secretion of basic gastric acid and the secretion of gastric acid at night caused by other factors such as food, it has no Anti-androgen effect without interfering with the metabolism of other drugs in the liver. It is mainly used clinically for the prevention and treatment of digestive ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4453A61K47/38A61P1/04A61P11/00
CPCA61K9/5047A61K31/4453A61P1/04A61P11/00
Inventor 张发香
Owner FUZHOU MINHAI PHARMA
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